No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
400 (estimated)
Sponsor
Boston Scientific Corporation · Industry
Who this trial is looking for
This trial is looking for adults with non-valvular atrial fibrillation who want a non-drug option to prevent strokes. Participants will receive a device designed to close a part of the heart that can cause blood clots.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with non-valvular atrial fibrillation.
I want an alternative to anticoagulation therapy.
I have a CHA2DS2-VASc score of 2 or higher if male, or 3 or higher if female.
I can provide written consent to join the trial.
I can attend follow-up visits after the procedure.
You may not be able to join if
I am pregnant or planning to become pregnant during the trial.
I have a life expectancy of less than 2 years.
I have serious heart or kidney problems.
I had a heart procedure or surgery within the last 30 days.
I have a significant active bleeding issue.
I have had a stroke or TIA in the last 90 days.
I have a known heart tumor.
I have a documented history of complex atheroma.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. The subject is of legal age to participate in the study per the laws of their respective geography.
2. The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
3.…
Inclusion Criteria:
1. The subject is of legal age to participate in the study per the laws of their respective geography.
2. The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
3. The subject has an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.
4. The subject is deemed to be suitable for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN Elite Device implant.
5. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
6. The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
7. The subject is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria:
1. The subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment upon study physician's discretion).
2. The subject has a documented life expectancy of less than 2 years.
3. The subject is currently enrolled, or plans to enroll, in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.
4. The subject has a known contraindication to percutaneous catheterization procedure or is contraindicated for transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
5. The subject has documented left ventricular ejection fraction (LVEF) \< 30%.
6. The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment.
7. The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU).
8. The subject has a known hypercoagulability disorder, mechanical heart valve in any position, known amyloid cardiomyopathy, or recurrent deep vein thrombosis (DVT).
9. The subject has known history of complex atheroma with mobile plaque of the descending aorta and/or aortic arch.
10. The subject has estimated glomerular filtration rate (eGFR) \<30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
11. The subject has a cardiac tumor.
12. The subject has signs/symptoms of acute or chronic pericarditis.
13. The subject has an active infection.
14. The subject has documented surgical closure of the left atrial appendage.
15. The subject has a history of atrial septal repair or has an ASD/PFO device.
16. The subject had a prior procedure with any commercial LAAC device that was either aborted or unsuccessful.
17. The subject is contraindicated to oral short-term anticoagulation post-implant.
18. The subject is contraindicated to Aspirin and P2Y12 inhibitor.
19. The subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
20. The subject has an active bleed, or the subject has a major bleeding event per ISTH definitions within the 90 days prior to enrollment. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event.
21. The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
22. The subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to enrollment.
23. The subject had or is planning to have any cardiac or non-cardiac invasive or surgical procedure within 30 days prior to or 60 days after the WATCHMAN Elite Device implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cataract surgery, endoscopy, etc.)
24. The subject had cardiac ablation within the 60 days prior to or plans to have a cardiac ablation within 60 days after the WATCHMAN Elite implant
25. Platelet count ≤ 100,000/μL
Pre-procedure Imaging Anatomical Exclusion Criteria:
26. The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU).
27. The subject has an existing pericardial effusion with a circumferential echo-free space \> 5mm, a significant mitral valve stenosis (i.e., MV area \<1.5 cm2), and/or there is evidence (clinically or echocardiographically) of tamponade physiology.
28. The subject has intracardiac thrombus, LAA sludge (gelatinous, non-adherent, intracavitary echo-density more layered than dense spontaneous echo contrast (SEC) seen continuously throughout cardiac cycle) or dense SEC visualized by TEE prior to device implant.
29. The subject has a high-risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion \> 15mm or length \> 15mm.
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